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ROPINIROLE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Ropinirole had no dose-related effect on ECG wave form and rhythm in young, healthy, male volunteers in the range of 0.01 to 2.5 mg.
  • Ropinirole had no dose-or exposure-related effect on mean QT intervals in healthy male and female volunteers titrated to doses up to 4 mg/day. The effect of ropinirole on QTc intervals at higher exposures achieved either due to drug interactions, hepatic impairment, or at higher doses has not been systematically evaluated.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
5
24087
Other ADRs
22684
38358903

Odds Ratio = 0.352

Drug Property Information



ATC Code(s):
  • N04BC04 - ropinirole
    • N04BC0 -
    • N04BC - Dopamine agonists
    • N04B - DOPAMINERGIC AGENTS
    • N04 - ANTI-PARKINSON DRUGS
    • N - NERVOUS SYSTEM
Active Ingredient:ROPINIROLE HYDROCHLORIDE
Active Ingredient UNII:D7ZD41RZI9
Drugbank ID:DB00268
PubChem Compound:5095
CTD ID:C046649
PharmGKB:PA164749035
CAS Number:91374-21-9
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 6.0 mg/day N04BC04
Chemical Structure:
SMILE Code:
CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1

Reference

N/A

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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

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